US20140326247A1 - Automatic tracheostoma speech valve (astv) fixation brace - Google Patents
Automatic tracheostoma speech valve (astv) fixation brace Download PDFInfo
- Publication number
- US20140326247A1 US20140326247A1 US14/342,136 US201214342136A US2014326247A1 US 20140326247 A1 US20140326247 A1 US 20140326247A1 US 201214342136 A US201214342136 A US 201214342136A US 2014326247 A1 US2014326247 A1 US 2014326247A1
- Authority
- US
- United States
- Prior art keywords
- brace
- patient
- atsv
- fixation
- tracheostoma
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
- A61M16/0497—Tube stabilizer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
- A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0206—Holding devices, e.g. on the body where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
Definitions
- German Gebrauchsmuster DE-U-2006 009 768 discloses a device for attaching a tracheal tube.
- a two part neck band is provided which has end connectors which can be fastened to attachment lips of a tracheal tube.
- the two parts can be connected around a patient's neck, e.g. using velcro or the like.
Abstract
Automatic tracheostoma speech valve (ATSV) fixation brace, comprising a fixation part (2) for keeping an ATSV base element (8) in position during use, and a holding part (3) for holding the ATSV fixation brace (1) to a patient, wherein at least the holding part (3) comprises a thermoplastic material, the thermoplastic material being moldable to the local anatomic shape of the patient.
Description
- The present invention relates to an automatic tracheostoma speech valve (ATSV) fixation brace.
- German patent publication DE-A-10 2006 056946 discloses a device for attaching a tracheal tube to a patient. A soft material type of skin protection is disclosed in combination with a flexible neck band. A hard plastic holder for a cannula is disclosed, also provided with a soft material protection material, but only at the location of the cannula holder. Although the publication mentions thermoplastic material, it is clear that the protection material is actually meant to be soft during actual use (silicone or elastomer material).
- German patent publication DE-U-20 2010 004297 discloses a shield for a tracheal cannula, with a flared form and lash eyes for a neck band to ensure proper holding of a tracheal tube. This shield is made of hard material in order to hold the tracheal tube firmly in position, in combination with the position of the neck band lashes.
- International patent publication WO2005/046776 discloses a headband for an oxygen mask, part of which is made of foamed plastic material. The disclosure teaches the skilled person to use foamed plastic material for protecting a person's back head against forces acting on the mask.
- The publication of German Gebrauchsmuster DE-U-2006 009 768 discloses a device for attaching a tracheal tube. A two part neck band is provided which has end connectors which can be fastened to attachment lips of a tracheal tube. The two parts can be connected around a patient's neck, e.g. using velcro or the like.
- American patent publication US 2008/0149107 discloses a holder for a medical tube, such as a tracheal tube. The holder can be fixed around a patient's neck using a flexible neck band, and allows fixation of tubes with varying diameter.
- International patent publication WO2008/127189 discloses a device for supporting and retaining medical appliances, such as tracheal cannulas and stoma stents. The device comprises a ring shaped supporting means for fixation of a tube, and an elongated fastening means which can be fixed to a patient's chest.
- When a patient has undergone a total laryngectomy, speech remains possible by pressing air through a tracheoesophageal speech valve into the esophagus, which however is only possible when closing the tracheostoma. This can be done manually, or using an automatic tracheostoma speech valve. In existing devices for holding a tracheostoma valve or automatic speech valve, it has been experienced that these still do not hold the valve sufficiently to have a patient feel comfortable with it. Normally, the automatic speech valve is fixed to the patient's skin using a plaster or the like, however, when actuating the automatic speech valve, a great pressure results on that plaster, and eventually the plaster will come off.
- The present invention seeks to provide an improved device for firmly fixing a tracheostoma valve of a laryngectomy patient
- According to the present invention, an automatic tracheostoma speech valve fixation brace according to the preamble defined above is provided, comprising a fixation part for keeping an ATSV base element (e.g. in the form of an adhesive base plate) in position during use, and a holding part for holding the ATSV fixation brace to a patient, wherein at least a part of the holding part adjacent to the fixation part is made of a thermoplastic material, the thermoplastic material being moldable to the local anatomic shape of the patient, such as a patient's neck.
- This allows to precisely mold the brace, which increases the wearing comfort, and provides a sufficiently strong fixation of the adhesive plaster on which the automatic speech valve is positioned, facilitating hands free speech. Even when using the fixation brace without using an actual ATSV, it can support the patient for manual speech. The present invention embodiments of the fixation brace contribute to the manual speech operations (use the patient's fingers to shut off the stoma), by better and more durably fixing the (ATSV) base element.
- Further embodiments and alternatives with specific advantages are described with reference to the drawings below.
- The present invention will be discussed in more detail below, using a number of exemplary embodiments, with reference to the attached drawings, in which
-
FIG. 1 shows a front view of an automatic tracheostoma speech valve fixation brace according to an embodiment of the present invention, -
FIG. 2 shows a front view of an automatic tracheostoma speech valve fixation brace according to a further embodiment of the present invention, and -
FIG. 3 shows a simplified diagram of an automatic tracheostoma speech valve fixation brace worn by a patient. - In the present invention embodiments an automatic tracheostoma speech valve (ATSV) 9 is fixed on a patient with an ATSV base element 8, e.g. in the form of an ATSV plaster 8, the
ATSV 9 and ATSV base element 8 being additionally supported by afixation brace 1. Thebrace 1 assures that the ATSV base element 8 normally applied for holding theATSV 9 to a patient is not stressed too much when the patient speaks. Thebrace 1 allows to take on the higher force exerted during speech by the patient on theATSV 9 and from there on to the ATSV base element 8. Thebrace 1 according to the present invention embodiments is (partly) made of a special material allowing to shape thebrace 1 to the (local) anatomic shape of the patient, such as an individual neck profile. Thebrace 1 is thus suitable for a large group of patients. As a result, the present brace embodiments can aid in improving the hands free speech of a patient who has undergone a total laryngectomy. - As shown in the schematic view of the embodiment shown in
FIG. 1 , theATSV fixation brace 1 comprises afixation part 2 for keeping an ATSV base element 8, and anATSV 9 positioned therein in position during use, and aholding part 3 for properly holding of theATSV fixation brace 1 to a patient, e.g. around a patient's neck. At least the holding part 3 (or at least the part thereof directly adjacent to the fixation part 2) comprises a thermoplastic material, the thermoplastic material being moldable to the local anatomic shape of the patient. This allows theATSV fixation brace 1 to be adapted to the specific local anatomic shape of an individual patient, resulting in a better fit and more convenience and comfort for the patient. In a further embodiment, also thefixation part 2 is made of the same thermoplastic material, the thermoplastic material being moldable to the local anatomic shape of the ATSV base element 8 when in use by the patient. - The
brace 1 in the embodiment shown is provided with aholding part 3 with two sections on each side of thefixation part 2. Theend parts co-operating connection elements connection elements brace 1 around a patient's neck, e.g. using anadditional band 3 a (seeFIG. 3 ). Theconnection elements end parts brace 1 by heating the thermoplastic material locally, sufficiently for attaching the connection elements 6, e.g. by molding a part of theend parts connection elements connection elements end parts - As mentioned the
connection elements - In a further specific embodiment, the
holding part 3 is shaped to allow a good fixture of thebrace 1 around a patient's neck without any further connection elements, e.g. by having theend parts holding part 3. - In a further embodiment, the
brace 1 is provided withend parts neck 7. In this embodiment, a further fixture, e.g. in the form of a flexible band is provided. The flexible band may also be provided as a band of which the length is adjustable. - In the embodiment shown, the
fixation part 2 is provided with a (substantially) round opening 4 which can hold theATSV 9 in position in an adhesive base element 8 of a patient. Thefixation part 2 can have an opening which is adaptable to different sizes of tracheostoma valves, e.g. by using a thin and flexible inner ring part of thefixation part 2. - The
fixation part 2 may be made of the same material as theholding part 3 as mentioned above, but furthermore this part may e.g. be made thicker thereby more readily keeping its shape in order to ensure a good fixation of theATSV 9 in the ATSV base element 8. Alternatively, the shape of thefixation part 2 may be made to better withstand the forces applied on the ATSV base element 8 during speech, e.g. by having a tube form part. Furthermore, the fixation part may comprises a coating at an interior surface thereof, e.g. from stainless steel, in order to improve the ability to insert and remove theATSV 9 from the ATSV base element 8. - As a major function of the
fixation part 2 is to provide support to the ATSV base element 8, the diameter of theopening 4 can be slightly larger than the diameter of theATSV 9 in a further embodiment. - In a further embodiment, which is shown schematically in
FIG. 2 , theATSV brace 1 further comprises achest extension part 2 a, extending from thefixation part 2. Thischest extension part 2 a may also be made from a thermoplastic material, e.g. the same material as the rest of theATSV brace 1. Thischest extension part 2 a may be attached to the patient's chest (e.g. using adhesive) and prevents theATSV brace 1 from deformation (e.g. for a patient having a long neck). -
FIG. 3 shows a simplified side view of a patient'sneck 7, wearing abrace 1 according to one of the invention's embodiments for holding anATSV 9. The part of the skin of a patient'sneck 7 is provided with a tracheostoma plaster serving as ATSV base element 8. The holdingpart 3 is as shown formed to the anatomic shape of the patient'sneck 7, e.g. closely following a collar bone curvature. In the embodiment shown, thefixation part 2 is keeping theATSV 9 in position by virtue of the holdingpart brace 1 around the patient'sneck 7. - Additionally, the
fixation part 2 is in close contact with the plaster 8 by molding the fixation part after it is activated. Furthermore, such a close contact allows e.g. using adhesives known as such. In an embodiment, thefixation part 2 comprises a contact surface (back side of fixation part 2) for contacting and applying an adhesive, for firm contact with the stoma plaster 8 on the patient's skin. - In one embodiment, the thermoplastic material remains moldable for a first time period (or working time) after being heated to at least a first threshold temperature (or activation temperature). In other words, the thermoplastic material remains moldable at ambient room temperature, in contact with a person, for at least the first time period. This allows to bring the fixation brace 1 (holding
part 3, or holdingpart 3 and fixation part 2) in a shape congruent with the local anatomic shape of the patient's body. - Thermoplastic material is a material which is rigid after cooled down to or being at ambient temperature for at least a cooling time period (or completion time). This allows the (anatomic) shape of the
brace 1 to stay permanent, i.e. after a first fitting, the patient can remain using thebrace 1 for a long period. Because of the specifically, individually shapedbrace 1, the patient can wear thebrace 1 with great comfort. - To further enhance the molding process and to enhance comfort during wearing, the thermoplastic material comprises a non-sticky surface, e.g. in the form of a coating, in a further embodiment. The non-sticky surface may be from a different material, or may result from proper treatment of the thermoplastic material.
- The
brace 1 can be made entirely from the same material. In one embodiment, thefixation part 2 and holdingpart 3 are integrally formed from a single sheet of the thermoplastic material. This makes fabrication of thebrace 1 according to the present invention very easy and economical. - In one embodiment, the thermoplastic material is cut to shape, e.g. using laser cutting techniques. After tooling, the thermoplastic material either stays smooth on its own, or can be post-treated very easily.
- The thermoplastic (memory) material used for the brace according to the present invention embodiments is e.g. a polycaprolactone (PCL) based material. This is a biodegradable polyester with a low melting point of around 60° C.
- Once softened, it can be molded by hand in the proper shape. If the temperature of an outer layer decreases, it becomes non-sticky, but still pliable and moldable.
- An example of such a thermoplastic material to be used is the Aquafit NS material commercially available from Orfit. This material is white when cooled down to ambient temperature, and is provided with a non-sticky layer (a coating dispersion of acrylat-urethane), allowing easier handling during molding of the brace. Activation can be easily monitored, as the color changes to transparent when reaching the activation temperature of about 65° C. This takes about 4-5 minutes when using heating in warm water. The working time of about 2 minutes is sufficient for molding the brace properly around a patient's neck. During a longer period (about 9 minutes, hardening time) the material is still flexible, but can no longer be molded. After about 25 minutes (completion time), the
brace 1 is ready to be worn by a patient. Other similar materials may be used as well. - When the thermoplastic material for the
brace 1 embodiments according to the present invention is reheated (i.e. heating to a temperature above a second threshold value), the material will regain its original shape (memory function), which allows to re-use thebrace 1, or to re-initiate a proper molding and fitting procedure. - The material is very suited for application as a
fixation brace 1, to support an adhesive base element 8 while using anATSV 9, as it is scentless and has a smooth surface. No irritation of skin occurs during regular use. - As the material can be molded after heating above a threshold value, the
brace 1 can be made suitable for almost every patient. After cooling down completely, thebrace 1 retains its shape, as a result of which the fitting of thebrace 1 is a simple and single event. It has been found that patients using thepresent brace 1 can speak for a longer period without hands (i.e. using the automatictracheostoma speech valve 9 without holding a hand to it). Also it was experienced that speaking is more comfortable as a sort of resistance is being felt which holds theautomatic speech valve 9 in position. - Furthermore, although a
brace 1 is now needed to be worn, it was found that a patient is getting accustomed to this quite quickly. Whenever a patient is getting used to using anATSV 9 with abrace 1 according to the present invention directly after a total laryngectomy, it was found that this present invention in one of its embodiments can be very helpful in speech revalidation of the patient. - The present invention embodiments have been described above with reference to a number of exemplary embodiments as shown in the drawings. Modifications and alternative implementations of some parts or elements are possible, and are included in the scope of protection as defined in the appended claims.
Claims (2)
1. Automatic tracheostoma speech valve (ATSV) fixation brace, comprising a fixation part for keeping an ATSV base element in position during use, and a holding part for holding the fixation brace to a patient, wherein at least a part of the holding part adjacent to the fixation part is made of a thermoplastic material, the thermoplastic material being moldable to the local anatomic shape of the patient.
2-15. (canceled)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NL2007326 | 2011-09-01 | ||
NL2007326A NL2007326C2 (en) | 2011-09-01 | 2011-09-01 | Automatic tracheostoma speech valve (atsv) fixation brace. |
PCT/NL2012/050600 WO2013032334A1 (en) | 2011-09-01 | 2012-08-31 | Automatic tracheostoma speech valve (atsv) fixation brace |
Publications (1)
Publication Number | Publication Date |
---|---|
US20140326247A1 true US20140326247A1 (en) | 2014-11-06 |
Family
ID=46832564
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/342,136 Abandoned US20140326247A1 (en) | 2011-09-01 | 2012-08-31 | Automatic tracheostoma speech valve (astv) fixation brace |
Country Status (6)
Country | Link |
---|---|
US (1) | US20140326247A1 (en) |
EP (1) | EP2744547B1 (en) |
JP (2) | JP2014527864A (en) |
CN (1) | CN103906544A (en) |
NL (1) | NL2007326C2 (en) |
WO (1) | WO2013032334A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20150306327A1 (en) * | 2012-12-11 | 2015-10-29 | Atos Medical Ab | Tracheostoma device holder |
WO2018009118A1 (en) * | 2016-07-06 | 2018-01-11 | Atos Medical Ab | Tracheostoma device holder |
US20200222649A1 (en) * | 2017-08-24 | 2020-07-16 | St. Joseph Health System | Tracheotomy device |
US11298490B2 (en) * | 2018-09-27 | 2022-04-12 | Atos Medical Ab | Tracheostoma device holder |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2717690B2 (en) * | 2017-12-22 | 2020-02-24 | Borja Barrones Daniel | CLAMPING ACCESSORY FOR A TRAQUEAL STOMA ASSEMBLY |
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-
2012
- 2012-08-31 WO PCT/NL2012/050600 patent/WO2013032334A1/en unknown
- 2012-08-31 JP JP2014528320A patent/JP2014527864A/en active Pending
- 2012-08-31 EP EP12758656.8A patent/EP2744547B1/en not_active Not-in-force
- 2012-08-31 CN CN201280054161.8A patent/CN103906544A/en active Pending
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20150306327A1 (en) * | 2012-12-11 | 2015-10-29 | Atos Medical Ab | Tracheostoma device holder |
US10384026B2 (en) * | 2012-12-11 | 2019-08-20 | Atos Medical Ab | Tracheostoma device holder |
WO2018009118A1 (en) * | 2016-07-06 | 2018-01-11 | Atos Medical Ab | Tracheostoma device holder |
US20200222649A1 (en) * | 2017-08-24 | 2020-07-16 | St. Joseph Health System | Tracheotomy device |
US11298490B2 (en) * | 2018-09-27 | 2022-04-12 | Atos Medical Ab | Tracheostoma device holder |
Also Published As
Publication number | Publication date |
---|---|
CN103906544A (en) | 2014-07-02 |
WO2013032334A1 (en) | 2013-03-07 |
NL2007326C2 (en) | 2013-03-04 |
EP2744547B1 (en) | 2018-03-28 |
JP2014527864A (en) | 2014-10-23 |
JP2017060856A (en) | 2017-03-30 |
EP2744547A1 (en) | 2014-06-25 |
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